US10500391B2 - Adapter for male connector and male connector with adapter - Google Patents

Abstract

An adapter (100) has a through hole (103). A first end portion (101) of the adapter includes a tubular portion (110) on which a first projection (111) and a second projection (112) are provided. The adapter can be connected to a male connector at a first position where a claw (32) of the male connector is engaged with the first projection (111) and at a second position where the claw (32) is engaged with the second projection (112). When the adapter is connected at the first position, a flow channel (11) of a male member (10) is sealed with a cover (4). When the adapter is connected at the second position, the adapter compressively deforms an outer circumferential wall (45) of the cover so that the flow channel of the male member is in communication with the through hole (103) of the adapter.

Description

TECHNICAL FIELD

The present invention relates to an adapter that is used by being attached to a male connector. The present invention also relates to a male connector provided with an adapter.

BACKGROUND ART

In hemodialysis, hemofiltration, a cardiac surgery operation, etc., blood drawn from a patient is subjected to a predetermined treatment, and then the processed blood is returned to the patient. For this purpose, an extracorporeal circuit is formed to circulate blood outside the body with the use of a mechanical external force such as a pump. In the extracorporeal circuit, a coupling portion including a male connector and a female connector is used to connect tubes through which blood flows.

If the male connector and the female connector are unintentionally disconnected from each other during blood circulation, the blood that is forced to flow by a pump or the like will leak out and, in the worst case, may result in a serious accident such as patient's death from loss of blood.

Therefore, the coupling portion is provided with a lock mechanism for maintaining the connection between the male connector and the female connector to prevent such a serious accident. For example,Patent Documents 1 to 3 disclose a lever lock male connector. This male connector includes a male member and an elastically swingable lock lever. A claw is formed on the leading end of the lock lever and can be engaged with the female connector. The connection between the male connector and the female connector is maintained by engaging (locking) the claw with the female connector while the male member of the male connector is inserted into the female connector.

Moreover, the male connector and the female connector are provided with a mechanism for preventing leakage of blood to the outside even if the male connector and the female connector are unintentionally disconnected from each other.Patent Documents 4, 5 disclose a cover that is attached to the male member of the male connector. The cover is made of an elastic material such as rubber. A straight line-shaped slit (cut portion) is formed in the top of the cover. In the initial state, the male connector is not connected to the female connector, and the male member is housed in the cover. Therefore, the cover covers an opening of a flow channel at the leading end of the male member. When the male connector is connected to the female connector, the cover is compressively deformed in the longitudinal direction of the male member, and the leading end of the male member is inserted into the female connector through the slit of the cover. Thus, the male member and the female connector are in communication with each other, and blood can flow between them. In this state, if the male connector is unintentionally disconnected from the female connector, the cover immediately returns to the initial state, closes the slit, and covers the opening of the male member. Therefore, blood will not leak from the male member to the outside of the cover.

Incidentally, an operation called “priming” is performed before circulating blood in the extracorporeal circuit. The priming operation introduces a fluid (e.g., physiological saline, which is referred to as a “priming fluid” in the following) into a flow channel of the extracorporeal circuit, and discharges air in the flow channel to the outside. This is because if blood circulation is started with air present in the extracorporeal circuit, the air may enter the blood vessels of a patient and create critical health issues.

In order to prevent air in the extracorporeal circuit from flowing into a patient, the priming operation is performed before forming the extracorporeal circuit, i.e., in a state where the male connector and the female connector, which will constitute the coupling portion, are separated from each other. In this state, the flow channel in the male member of the male connector needs to be filled with the priming fluid.

CITATION LISTPatent Documents

Patent Document 1: JP 2004-000483 A

Patent Document 2: WO 2013/154050

Patent Document 3: JP 2015-073664 A

Patent Document 4: JP 2012-254142 A

Patent Document 5: JP 2013-165830 A

Patent Document 6: JP 2013-252165 A

DISCLOSURE OF INVENTIONProblem to be Solved by the Invention

However, as the male member is provided with the cover, the cover covers the opening at the leading end of the male member in the initial state before the male connector is connected to the female connector. In this state, it is difficult to introduce the priming fluid into the flow channel of the male member. Therefore, it is desirable to make it possible to introduce the priming fluid into the male connector having the cover.

Moreover, the operation of introducing the priming fluid is desired to be simple. Further, it is also desirable to prevent bacteria or the like from entering the flow channel of the male member during the introduction of the priming fluid.

It is an object of the present invention to easily and hygienically introduce a priming fluid into a lever lock male connector having a cover.

Means for Solving Problem

An adapter of the present invention is attachable to and detachable from a male connector. The male connector includes a rod-shaped male member that has a flow channel, a lock lever that is located opposite to the male member, a claw that protrudes from the lock lever toward the male member, and a cover that houses the male member. The lock lever is elastically swingable so that the claw moves away from the male member. The cover includes an outer circumferential wall that is elastically and compressively deformable in a longitudinal direction of the male member, and a head portion that is provided at one end of the outer circumferential wall. The cover is configured such that a leading end of the male member protrudes from the head portion when the outer circumferential wall is compressively deformed. The adapter includes a first end portion and a second end portion. The adapter has a through hole that penetrates the adapter and allows the first end portion to be in communication with the second end portion. The first end portion includes a hollow tubular portion in which the through hole is provided. A first projection and a second projection are provided on an outer circumferential surface of the tubular portion, and the second projection is located on a base end side of the tubular portion with respect to the first projection. The adapter can be connected to the male connector at a first position where the claw of the male connector is engaged with the first projection and at a second position where the claw of the male connector is engaged with the second projection. When the adapter is connected to the male connector at the first position, the flow channel of the male member is sealed with the cover. When the adapter is connected to the male connector at the second position, the adapter compressively deforms the outer circumferential wall of the cover so that the flow channel of the male member is in communication with the through hole of the adapter.

An male connector provided with an adapter of the present invention includes the male connector and the adapter of the present invention.

Effects of the Invention

The adapter of the present invention can be connected to a lever lock male connector having a cover at two positions, i.e., the first position and the second position. Only a simple operation of shifting the adapter from the first position to the second position is required to be able to introduce a priming fluid into the male connector.

The male connector to which the adapter is connected at the first position is stored. Then, the adapter is shifted to the second position immediately before performing the priming operation. This reduces the probability that bacteria or the like will enter the flow channel of the male member during the introduction of the priming fluid. Thus, the priming fluid can be hygienically introduced into the male connector.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is an exploded perspective view of an embodiment of a male connector applicable to an adapter of the present invention and a screw lock connector to be connected to the male connector.

FIG. 2A is a perspective view of a connector main body of the male connector when viewed from above.

FIG. 2B is a perspective view of the connector main body when viewed from below.

FIG. 2C is a front view of the connector main body.

FIG. 2D is a side view of the connector main body.

FIG. 2E is a plan view of the connector main body.

FIG. 2F is a cross-sectional view of the connector main body taken along a verticalplane containing line2F-2F inFIG. 2D.

FIG. 2G is a cross-sectional view of the connector main body taken along a verticalplane containing line2G-2G inFIG. 2C.

FIG. 3A is a perspective view of a cover of the male connector shown inFIG. 1 when viewed from above.

FIG. 3B is a perspective view of the cover when viewed from below.

FIG. 3C is a cross-sectional view of the cover.

FIG. 4A is a perspective view of the male connector shown inFIG. 1 when viewed from above.

FIG. 4B is a cross-sectional view of the male connector.

FIG. 4C is another cross-sectional view of the male connector.

FIG. 5A is a perspective view of a luer main body shown inFIG. 1.

FIG. 5B is a cross-sectional view of the luer main body.

FIG. 6A is a perspective view of a lock nut shown inFIG. 1 when viewed from above.FIG. 6B is a perspective view of the lock nut when viewed from below.FIG. 6C is a plan view of the lock nut.FIG. 6D is a cross-sectional view of the lock nut.

FIG. 7A is a perspective view of a screw lock connector when viewed from above.FIG. 7B is a cross-sectional view of the screw lock connector.

FIG. 8A is a side view showing a state in which the male connector and the screw lock connector are connected to each other.

FIG. 8B is a cross-sectional view showing a state in which the male connector and the screw lock connector are connected to each other.

FIG. 9A is a perspective view of a female connector to be connected to the male connector.

FIG. 9B is a cross-sectional view of the female connector.

FIG. 10 is a perspective view showing the male connector and the female connector immediately before they are connected.

FIG. 11A is a perspective view showing a state in which the male connector and the female connector are connected to each other.

FIG. 11B is a cross-sectional view showing a state in which the male connector and the female connector are connected to each other.

FIG. 12A is a perspective view of an adapter according toEmbodiment 1 of the present invention when viewed from a first end portion of the adapter.

FIG. 12B is a perspective view of the adapter according toEmbodiment 1 of the present invention when viewed from a second end portion of the adapter.

FIG. 12C is a side view of the adapter according toEmbodiment 1 of the present invention.

FIG. 12D is a cross-sectional perspective view of the adapter according toEmbodiment 1 of the present invention.

FIG. 13 is a perspective view of the adapter according toEmbodiment 1 of the present invention immediately before it is connected to the male connector.

FIG. 14A is a perspective view of the adapter according toEmbodiment 1 of the present invention when it is attached to the male connector at the first position.

FIG. 14B is a cross-sectional view of the adapter and the male connector shown inFIG. 14A

FIG. 14C is another cross-sectional view of the adapter and the male connector shown inFIG. 14A

FIG. 15 is a perspective view showing a state in which a tube constituting an extracorporeal circuit is connected to the male connector to which the adapter according toEmbodiment 1 of the present invention is connected at the first position.

FIG. 16A is a perspective view showing a state in which the adapter according toEmbodiment 1 of the present invention is attached to the male connector at the second position while the tube constituting an extracorporeal circuit is being connected to the male connector.

FIG. 16B is a cross-sectional view of the adapter and the male connector shown inFIG. 16A

FIG. 16C is another cross-sectional view of the adapter and the male connector shown inFIG. 16A

FIG. 17A is a perspective view of a drain connector that is to be attached to the adapter according toEmbodiment 1 of the present invention for priming.FIG. 17B is a cross-sectional view of the drain connector.

FIG. 18A is a perspective view for explaining a first priming method for the male connector using the adapter according toEmbodiment 1 of the present invention.

FIG. 18B is a cross-sectional view ofFIG. 18A

FIG. 19 is a perspective view showing a state immediately before performing a second priming method for the male connectors using the adapters according toEmbodiment 1 of the present invention.

FIG. 20A is a perspective view for explaining the second priming method for the male connectors using the adapters according toEmbodiment 2 of the present invention.

FIG. 20B is a cross-sectional view ofFIG. 20A

FIG. 21A is a perspective view of an adapter according toEmbodiment 2 of the present invention.

FIG. 21B is a side view of the adapter according toEmbodiment 2 of the present invention.

FIG. 21C is a cross-sectional perspective view of the adapter according toEmbodiment 2 of the present invention.

FIG. 22 is a perspective view of the adapter according toEmbodiment 2 of the present invention immediately before it is connected to male connectors.

FIG. 23A is a perspective view of the adapter according toEmbodiment 2 of the present invention when it is attached to the male connectors at the first position.

FIG. 23B is a cross-sectional view of the adapter and the male connectors shown inFIG. 23A.

FIG. 23C is another cross-sectional view of the adapter and the male connectors shown inFIG. 23A.

FIG. 24 is a perspective view showing a state in which a tube constituting an extracorporeal circuit is connected to each of the male connectors to which the adapter according toEmbodiment 2 of the present invention is connected at the first position.

FIG. 25A is a perspective view showing a state in which the adapter according toEmbodiment 2 of the present invention is attached to the male connectors at the second position while the tube constituting an extracorporeal circuit is being connected to each of the male connectors.

FIG. 25B is a cross-sectional view of the adapter and the male connectors shown inFIG. 25A.

FIG. 25C is another cross-sectional view of the adapter and the male connectors shown inFIG. 25A.

DESCRIPTION OF THE INVENTION

As described above, in the initial state of the lever lock male connector having the cover, the cover closes the opening of the flow channel of the male member. As long as the cover closes the opening of the male member, it is difficult to introduce a priming fluid into the flow channel of the male member.

The present inventors conducted studies to examine the priming operation by attaching a dummy member to a male connector. The dummy member was a hollow tubular member with an internal diameter larger than the external diameter of a male member. The dummy member had a projection on its outer circumferential surface. A claw of a lock lever of the male connector was to be engaged with the projection of the dummy member. The male member of the male connector was inserted into the dummy member, and the claw was engaged with the projection of the dummy member. When the dummy member was attached to the male member, the cover was compressively deformed by the dummy member, as in the case where a female connector was connected to the male connector, and the male member penetrated the cover. Thus, the male member and the dummy member were in communication with each other. In this state, a priming fluid was allowed to flow from the male member to the dummy member.

Such a dummy member had previously been prepared separately from the male connector. For the priming operation, first, the dummy member was attached to the male connector. Then, a priming fluid was introduced into the male member. Subsequently, the dummy member was detached from the male connector, and a female connector was connected to the male connector, instead of the dummy member.

However, this method was found to have the following problems: (1) since the dummy member had to be prepared separately from the male connector and attached to the male connector before the priming operation, operations for storage and attachment of the dummy member were complicated; (2) since the dummy member had to be attached to the male connector before the priming operation, there was a possibility that bacteria would enter the flow channel of the male member via the dummy member.

To deal with the above problems, the present inventors conducted studies to examine sterilization and packaging of the male connector and the dummy member in a state in which the dummy member was attached to the male connector (i.e., a state in which the male member and the dummy member were in communication with each other). When extracorporeal blood circulation was carried out in medical institutions such as hospitals, the package was opened to take out the male connector to which the dummy member was attached, and then the priming operation was performed. Thereafter, the dummy member was detached from the male connector, and the female connector was connected to the male connector, instead of the dummy member. This method was able to solve the above two problems because the dummy member had been attached to the male connector and sterilized before they were delivered to medical institutions.

However, the cover was compressively deformed by the dummy member when it was attached to the male connector. In this state, if the cover was allowed to stand for a long time, the cover would be permanently deformed, so that the elastic recovery force for return of the cover to its initial state would be reduced. Thus, the separation of the male connector from the female connector could create a situation where the cover did not return to the initial state and failed to close the opening of the flow channel of the male member. Consequently, the cover could not exhibit the effect of preventing leakage of blood to the outside if the male connector was unintentionally disconnected from the female connector during blood circulation.

The present inventors further conducted intensive studies to find an adapter that is attachable to a lever lock male connector having a cover at two positions, and have completed the present invention.

The adapter of the present invention is attachable to and detachable from a male connector. The male connector includes a rod-shaped male member that has a flow channel, a lock lever that is located opposite to the male member, a claw that protrudes from the lock lever toward the male member, and a cover that houses the male member. The lock lever is elastically swingable so that the claw moves away from the male member. The cover includes an outer circumferential wall that is elastically and compressively deformable in a longitudinal direction of the male member, and a head portion that is provided at one end of the outer circumferential wall. The cover is configured such that a leading end of the male member protrudes from the head portion when the outer circumferential wall is compressively deformed. The adapter includes a first end portion and a second end portion. The adapter has a through hole that penetrates the adapter and allows the first end portion to be in communication with the second end portion. The first end portion includes a hollow tubular portion in which the through hole is provided. A first projection and a second projection are provided on an outer circumferential surface of the tubular portion, and the second projection is located on a base end side of the tubular portion with respect to the first projection. The adapter can be connected to the male connector at a first position where the claw of the male connector is engaged with the first projection and at a second position where the claw of the male connector is engaged with the second projection. When the adapter is connected to the male connector at the first position, the flow channel of the male member is sealed with the cover. When the adapter is connected to the male connector at the second position, the adapter compressively deforms the outer circumferential wall of the cover so that the flow channel of the male member is in communication with the through hole of the adapter.

It is preferable that when the adapter is connected to the male connector at the second position, a liquid-tight seal is formed between the tubular portion and the cover. This can prevent a priming fluid from leaking between the adapter and the cover during the priming operation.

The tubular portion may include an annular rib that surrounds the through hole. In this case, it is preferable that the liquid-tight seal is formed by abutting of a leading end of the annular rib against the head portion of the cover. This allows the annular rib and the head portion to be in contact with each other in a small area. Therefore, the sealing between the adapter and the cover is improved.

It is preferable that when the adapter is connected to the male connector at the first position, the outer circumferential wall of the cover is not substantially compressively deformed. Moreover, it is preferable that when the adapter is in the first position, the adapter is spaced apart from the cover. Thus, even if the male connector to which the adapter is connected at the first position is allowed to stand for a long period of time, the elastic recovery force of the outer circumferential wall of the cover will not be reduced.

The adapter may further include a large diameter portion on a base end of the tubular portion. The large diameter portion may protrude in a radial direction compared to the first projection and the second projection. Thus, the large diameter portion abuts against the male connector (particularly the leading end of a hood of the male connector), and thus can prevent the adapter from being inserted into the male connector (particularly the hood) more than necessary. This is advantageous in preventing damage to the cover due to excessive deformation caused by the adapter.

In the above configuration, the male connector may further include a tubular hood that surrounds the male member. In this case, when the adapter is connected to the male connector at the second position, the large diameter portion may abut against a leading end of the hood. Thus, the adapter cannot be inserted into the hood to a depth deeper than the second position, which can reliably prevent damage to the cover.

The first projection and the second projection may be annular projections that continuously extend in a circumferential direction. Thus, the claw of the male connector can be engaged with the first projection and the second projection regardless of the position of the adapter in the direction of rotation relative to the male connector.

The second projection may have a tapered surface on an end edge thereof facing the first projection, and an external diameter of the tapered surface gradually decreases toward the first projection. Thus, the adapter can easily be shifted from the first position to the second position only by pushing the adapter into the male connector.

The second end portion may include a male luer in which the through hole is provided. An outer circumferential surface of the male luer may be a tapered surface whose external diameter gradually decreases toward a leading end. Thus, a tubular member (e.g., a drain connector) having a female tapered surface that is fitted to the tapered surface of the male lure can be connected to the second end portion in a liquid-tight manner. When the tubular member is fixed to a container, a priming fluid can be stably discharged into the container.

In the above configuration, the second end portion may further include an outer cylinder that surrounds the male luer. A screw structure may be formed on an inner circumferential surface of the outer cylinder. Thus, a tubular member (e.g., a drain connector) having a male thread that is to be screwed into the screw structure, in addition to the female tapered surface that is fitted to the tapered surface of the male luer, can be firmly connected to the second end portion in a liquid-tight manner.

Alternatively, the second end portion of the adapter may be configured symmetrically to the first end portion. This allows two male connectors to be connected at the first position and the second position via the adapter, respectively. Thus, a priming fluid can be simultaneously introduced into the two male connectors.

A male connector provided with an adapter of the present invention includes the above male connector and the above adapter of the present invention.

It is preferable that the male connector provided with the adapter are sterilized and packaged in a state in which the adapter is connected to the male connector at the first position. Thus, the adapter and the male connector can be maintained in good sanitary conditions immediately before performing the priming operation. In medical institutions such as hospitals, it is only necessary to open the package and shift the adapter to the second position so that a priming fluid can be introduced into the male connector. This will reduce the burden of the priming operation on medical institutions. Moreover, the adapter does not have to be stored separately from the male connector. Therefore, this will also reduce the burden of the management of equipment in medical institutions.

Hereinafter, the present invention will be described in detail while showing preferred embodiments thereof. However, it goes without saying that the present invention is not limited to the embodiments below. In the drawings that will be referred to in the following description, only the main members of constituent members of the embodiments of the present invention are shown in a simplified manner for the sake of convenience of description. Accordingly, the present invention may include optional members that are not shown in the drawings below. Moreover, it should be understood that the members shown in the drawings below may be changed or omitted within the scope of the present invention.

An adapter of the present invention is attachable to and detachable from a male connector. The male connector is connected to a tube constituting an extracorporeal circuit.

Before describing the adapter of the present invention, the male connector applicable to the adapter and a connection structure of the male connector and the tube will be described.

FIG. 1 is an exploded perspective view of amale connector1 and ascrew lock connector6 according to an embodiment of the present invention. Themale connector1 includes a connectormain body2 and acover4. Thescrew lock connector6 includes a luermain body7 and alock nut8. Thescrew lock connector6 is connected to the leading end of asoft tube9 constituting an extracorporeal circuit. Themale connector1 is removably connected to thescrew lock connector6.

Hereinafter, the various portions will be sequentially described.

1. Male Connector

1.1. Connector Main Body

A connectormain body2 constituting amale connector1 will be described.FIG. 2A is a perspective view of the connectormain body2 when viewed from above, andFIG. 2B is a perspective view of the connectormain body2 when viewed from below.FIGS. 2C, 2D, and 2E are a front view, a side view, and a plan view, in that order, of the connectormain body2.FIG. 2F is a cross-sectional view of the connectormain body2 taken along a verticalplane containing line2F-2F inFIG. 2D.FIG. 2G is a cross-sectional view of the connectormain body2 taken along a verticalplane containing line2G-2G inFIG. 2C. InFIGS. 2F and 2G, an alternate long andshort dash line2arepresents a central axis of the connectormain body2. Thecentral axis2aalso serves as the central axis of the male connector1 (seeFIG. 1).

For the sake of convenience of the following description, the direction that is parallel to thecentral axis2ais referred to as a “vertical direction”, the direction that is parallel to a plane that is perpendicular to thecentral axis2ais referred to as a “horizontal direction”, the direction that is orthogonal to thecentral axis2ais referred to as a “radial direction” or a “diameter direction”, and the direction of rotation about thecentral axis2ais referred to as a “circumferential direction”. With respect to the radial direction, the side nearer thecentral axis2ais referred to as the “inner side”, and the side further from thecentral axis2ais referred to as the “outer side”. “Up” and “down” are defined based onFIGS. 2F and 2G. However, the “vertical direction” and the “horizontal direction” do not mean the actual orientation of themale connector1 during usage.

As shown inFIGS. 2F and 2G, the connectormain body2 includes amale luer10 serving as a male member. Themale luer10 is a rod-shaped member extending along and coaxially with thecentral axis2a. In this embodiment, a portion of the outer circumferential surface (side surface) of themale luer10 that is near a leadingend10aand that is to be inserted into a female connector (aseptum810, which will be described later) constitutes a cylindrical surface whose external diameter is constant with respect to the direction of thecentral axis2a, and a portion of the outer circumferential surface of themale luer10 that is near abase end portion13 constitutes a tapered surface (conical surface) whose external diameter decreases as the distance to theleading end10adecreases. However, the shape of the outer circumferential surface of themale luer10 is not limited to the above-described shape, and may be selected as desired. For example, the outer circumferential surface of themale luer10 may be a cylindrical surface whose external diameter is constant from thebase end portion13 to theleading end10a. Alternatively, the outer circumferential surface of themale luer10 may be a smooth curved surface whose external diameter gradually decreases from thebase end portion13 toward the leadingend10a.

Aflow channel11 is formed along thecentral axis2awithin themale luer10. Theflow channel11 is not open in theleading end10aof themale luer10. Twolateral holes12 that are in communication with theflow channel11 are formed in the outer circumferential surface of themale luer10 at respective positions near the leadingend10a. Eachlateral hole12 penetrates themale luer10 in the radial direction and is open in the outer circumferential surface of themale luer10. It should be noted that the number oflateral holes12 is not necessarily required to be two, and may also be one, or three or more.

Abase15 protrudes outward from thebase end portion13 of themale luer10. Thebase15 is a flat plate-shaped member that is parallel to the horizontal direction. As can be understood fromFIG. 2E, when viewed along thecentral axis2a, thebase15 has a substantially elliptical shape with amajor axis15aand aminor axis15b.

Atubular portion17 protrudes downward from thebase15. Thetubular portion17 has a substantially cylindrical shape that is coaxial with thecentral axis2a, and a flow channel that is in communication with theflow channel11 of themale luer10 is formed in thetubular portion17. An innercircumferential surface17aof thetubular portion17 is a female tapered surface (e.g., a 6% tapered surface) whose internal diameter increases as the distance from the base15 increases. Amale thread18 is formed on the outer circumferential surface of thetubular portion17.

Ahood20 extends upright from the outer end edge of the base15 toward the same side as themale luer10. Thehood20 has a hollow tubular shape that surrounds themale luer10. Thehood20 is open upward. A leading end (upper end)20aof thehood20 that surrounds anopening21 has a circular shape that is coaxial with thecentral axis2a. The leadingend20aof thehood20 is located at a higher position than the leadingend10aof themale luer10.

A pair of cut-outs23 are provided in a side wall of thehood20. The cut-outs23 are holes (openings) penetrating thehood20 in the radial direction. The pair of cut-outs23 are located opposite to each other in the direction of themajor axis15a(seeFIG. 2E) with thecentral axis2a(or the male luer10) disposed between them. Each cut-out23 has an inverted “U” shape (seeFIG. 2D), and a lower end thereof reaches thebase15. However, the cut-outs23 do not reach theleading end20aof thehood20.

As is best shown inFIG. 2F, a pair of lock levers (hereinafter simply referred to as “levers”)30 are located opposite to each other in the direction of themajor axis15a(seeFIG. 2E) with thecentral axis2adisposed between them. Thelevers30 are rectangular strip-shaped members that extend substantially parallel to thecentral axis2a. Thelevers30 are connected to the outer end edge of thebase15. Eachlever30 includes a lockingportion31 that is disposed on the same side (upper side) as themale luer10 with respect to thebase15 and an operatingportion35 that is disposed on the opposite side (lower side) to themale luer10 with respect to thebase15. A portion of eachlever30 which is located between the lockingportion31 and the operatingportion35 and to which thebase15 is connected is referred to as alever base portion39. The lockingportions31 each faces themale luer10 and the operatingportions35 each faces thetubular portion17.

The lockingportions31 are disposed within the respective cut-outs23 that are formed in thehood20. In other words, the lockingportions31 are surrounded by the respective inverted “U”-shapedslits23 that penetrate thehood20 in the radial direction (seeFIG. 2D).

Aclaw32 protrudes toward themale luer10 from a surface (inner surface) of each lockingportion31 that faces themale luer10. Eachclaw32 includes aninclined surface32aand anengagement surface32b. Theinclined surface32ais inclined so that the distance from themale luer10 increases as the distance from the base15 increases. Theengagement surface32bis a flat surface that is disposed nearer to the base15 than theinclined surface32aand that is substantially parallel to a horizontal plane. As shown inFIG. 2E, when viewed from above, the top portion (portion that is nearest to the male luer10) of eachclaw32 protrudes toward themale luer10 beyond the leadingend20athat surrounds theopening21 of thehood20.

As will be described later, when themale connector1 is connected to afemale connector800, theclaws32 are engaged with the female connector800 (seeFIG. 11B, which will be described later). Thelevers30 function as a “lever-type lock mechanism” that maintains the state in which themale connector1 and thefemale connector800 are connected to each other. In other words, themale connector1 is a lever lock male connector.

Since the twolevers30 are disposed at respective positions that are symmetrical with respect to thecentral axis2a(i.e., the male luer10), the twoclaws32 can be engaged with thefemale connector800 at respective positions that are symmetrical with respect to thecentral axis2a. Accordingly, thefemale connector800 can be stably held, and thus the reliability of the lever-type lock mechanism is improved. The state in which theclaws32 are engaged with thefemale connector800 is referred to as a “locked state”.

Eachlever30 has a mechanical strength that is high enough for theentire lever30 from the upper end (locking portion31) to the lower end (operating portion35) to be regarded as a substantially rigid body. In contrast, the mechanical strength of the base15 that joins thebase end portion13 of themale luer10 to eachlever30 is relatively low. Therefore, when a force F acting toward thecentral axis2ais applied to the operatingportions35 as shown inFIG. 2F, thebase15 is elastically deformed and bent, thereby allowing thelevers30 to swing (or pivot) so that the lockingportions31 and theclaws32 formed on therespective locking portions31 move away from the male luer10 (in the directions of arrows A).

As shown inFIGS. 2B and 2G, a pair ofholes16 penetrating the base15 in the vertical direction are formed in thebase15. Theholes16 are disposed on theminor axis15b(seeFIG. 2E) of the base15 having a substantially elliptical shape.

As shown inFIG. 2A, the shape of the outer circumferential surface of the connectormain body2 that is located above thebase15 is a substantially curved surface that smoothly connects the circular shape of theleading end20aof thehood20 and the substantially elliptical shape at the position of thebase15. This curved surface is constituted by the outer circumferential surface of thehood20 and the outer circumferential surfaces of thelevers30.

It is preferable that the connectormain body2 is made of a hard material. Specifically, a resin material such as polyacetal, polycarbonate, polystyrene, polyamide, polypropylene, or rigid polyvinyl chloride may be used. The connectormain body2 can be integrally produced as a single component through injection molding or the like using such a resin material.

1.2. Cover

Acover4 that constitutes themale connector1 will be described below.FIG. 3A is a perspective view of thecover4 when viewed from above,FIG. 3B is a perspective view of thecover4 when viewed from below, andFIG. 3C is a cross-sectional view of thecover4. Thecover4 includes ahead portion41, an outercircumferential wall45, and abase portion48 in this order from the top to the bottom. As shown inFIG. 3C, thecover4 has a substantially tubular shape with a space penetrating thecover4 in the vertical direction.

Thecover4 is integrally formed as a single component using a soft material (so-called elastomer) having rubber elasticity (or flexibility). The material for thecover4 is not limited, and may be, e.g., isoprene rubber, silicone rubber, butyl rubber, or a thermoplastic elastomer.

As shown inFIG. 3C, a throughhole42 is formed penetrating thehead portion41 in the vertical direction. It is preferable that the inner circumferential surface of the throughhole42 has a shape that conforms to the outer circumferential surface of themale luer10 so as to come into intimate contact with the outer circumferential surface of themale luer10 of the connectormain body2. In this embodiment, the inner circumferential surface of the throughhole42 is a cylindrical surface whose internal diameter is constant with respect to the vertical direction. It is preferable that the internal diameter of the throughhole42 is equal to or slightly smaller than the external diameter of themale luer10 of the connectormain body2.

As shown inFIG. 3A, a dome-shapedprotrusion44 that protrudes upward is provided in a circular area in the middle of anupper surface43 of thehead portion41. The throughhole42 is open in the center of theprotrusion44. Theupper surface43 of thehead portion41, which surrounds theprotrusion44, constitutes an annular flat surface that is parallel to the horizontal direction.

When a compressive force in the vertical direction is applied to thecover4, the outercircumferential wall45 is elastically and compressively deformed so that its vertical dimension is reduced (seeFIG. 11B, which will be described later). As shown inFIG. 3C, the outercircumferential wall45 has a larger internal diameter than the throughhole42 of thehead portion41. When thecover4 is attached to the connectormain body2, the outercircumferential wall45 is spaced apart from themale luer10 in the radial direction (seeFIGS. 4B and 4C, which will be described later). Thus, it is less likely that the inner circumferential surface of the outercircumferential wall45 will collide with themale luer10 when the outercircumferential wall45 is compressively deformed in the vertical direction. This is advantageous in increasing the amount of compressive deformation of the outercircumferential wall45 in the vertical direction.

Moreover, the outercircumferential wall45 has tapered (conical) portions and cylindrical portions that are alternately arranged in the vertical direction. In the tapered portions, the external and internal diameters of the outercircumferential wall45 increase as the distance from thehead portion41 increases. In the cylindrical portions, the external and internal diameters of the outercircumferential wall45 are constant with respect to the vertical direction. Thus, the outercircumferential wall45 as a whole has a conical shape that becomes gradually narrower toward thehead portion41. When a compressive force in the vertical direction is applied to thecover4, this shape allows the outercircumferential wall45 to be deformed so that the tapered portions are depressed into the cylindrical portions directly under the respective tapered portions (seeFIG. 11B, which will be described later). This is advantageous in increasing the amount of compressive deformation of the outercircumferential wall45 in the vertical direction.

Rib-shapedprojections46 are provided on the outer surface of the outercircumferential wall45 in the vertical direction. The rib-shapedprojections46 protrude outward from the outercircumferential wall45 and locally increase the thickness (i.e., the radial dimension) of the outercircumferential wall45. The rib-shapedprojections46 prevent buckling deformation of the outercircumferential wall45 when a compressive force in the vertical direction is applied to thecover4.

Thebase portion48 has aflat bottom surface48a. A pair of fixingprojections49 protrude downward from thebottom surface48a. A fixingclaw49aprotrudes outward from the outer surface of each fixingprojection49. The fixingprojections49 and the fixingclaws49aare used to fix thecover4 to the connectormain body2.

1.3. Assembling of Male Connector

As shown inFIG. 1, thecover4 is inserted into thehood20 from above the connectormain body2.FIG. 4A is a perspective view of themale connector1 when viewed from above, with thecover4 attached to the connectormain body2.FIG. 4B is a cross-sectional view of themale connector1 taken along a plane containing thecentral axis2aand themajor axis15a(seeFIG. 2E).FIG. 4C is a cross-sectional view of themale connector1 taken along a plane containing thecentral axis2aand theminor axis15b(seeFIG. 2E).

As shown inFIG. 4C, the fixingprojections49 of thecover4 are inserted into therespective holes16 that are provided in thebase15 of the connectormain body2. The fixingclaws49ahave passed through theholes16 and are engaged with the lower surface of thebase15. Thebottom surface48aof thecover4 is in intimate contact with the upper surface of the base15 (seeFIG. 4B).

The leadingend10aand its neighboring portion of themale luer10 are inserted into the throughhole42 of thehead portion41 of thecover4. The leadingend10aof themale luer10 is exposed in the throughhole42 of thehead portion41. The inner circumferential surface of the throughhole42 is appropriately deformed in accordance with the external shape of the outer circumferential surface of themale luer10 and is in intimate contact with that outer circumferential surface. The openings of the lateral holes12 of themale luer10 are closed off in a liquid-tight manner by the inner circumferential surface of the throughhole42.

The outercircumferential wall45 of thecover4 is spaced apart from themale luer10 in the radial direction. Thus, a liquid-tight space is formed between thecover4 and the connectormain body2. Moreover, the outercircumferential wall45 is spaced apart from both thehood20 and thelevers30 in the radial direction.

In the present invention, as shown inFIGS. 4A to 4C, a state in which substantially no external force acts on thelevers30, and thecover4 is not compressively deformed in the vertical direction is referred to as the “initial state” of themale connector1. The shape of thecover4 in the initial state is referred to as an “initial shape”.

2. Screw Lock Connector

2.1. Luer Main Body

A luermain body7 that constitutes ascrew lock connector6 will be described below.FIG. 5A is a perspective view of the luermain body7, andFIG. 5B is a cross-sectional view of the luermain body7.

The luermain body7 has a substantially cylindrical shape as a whole, in which a through hole (flow channel)71 along the longitudinal direction of the luermain body7 is formed. The luermain body7 includes amale luer72, atubular portion75, and a connectingportion79 in this order from the top to the bottom.

An outercircumferential surface72aof themale luer72 is a male tapered surface (e.g., a 6% tapered surface) whose external diameter gradually decreases toward the leading end. The outer circumferential surface of thetubular portion75 is a cylindrical surface whose external diameter is constant with respect to the vertical direction. A pair of protrudingportions76 protrude outward from the outer circumferential surface of thetubular portion75. Anannular projection77 continuously extending in the circumferential direction is provided at the boundary between themale luer72 and thetubular portion75. Theannular projection77 has an external diameter that is larger than those of themale luer72 and thetubular portion75.

It is preferable that the luermain body7 is made of a hard material. Specifically, a resin material such as polyacetal, polycarbonate, polystyrene, polyamide, polypropylene, or rigid polyvinyl chloride may be used. The luermain body7 can be integrally produced as a single component through injection molding or the like using such a resin material.

2.2 Lock Nut

Alock nut8 that constitutes thescrew lock connector6 will be described below.FIG. 6A is a perspective view of thelock nut8 when viewed from above,FIG. 6B is a perspective view of thelock nut8 when viewed from below,FIG. 6C is a plan view of thelock nut8, andFIG. 6D is a cross-sectional view of thelock nut8. Thelock nut8 has a hollow, substantially cylindrical shape as a whole.

The outer circumferential surface of thelock nut8 is constituted by two cylindrical surfaces having different external diameters. A plurality ofribs83 protrude outward from the upper cylindrical surface having a relatively large external diameter. Theribs83 extend in the vertical direction. In this embodiment, the outer circumferential surface of thelock nut8 is constituted by the two cylindrical surfaces; however, the present invention is not limited thereto. For example, the entire outer circumferential surface from the upper end to the lower end may be constituted by a single cylindrical surface. Alternatively, the outer circumferential surface may contain a surface (e.g., a polygonal prism-shaped surface) other than a cylindrical surface. Theribs83 may be omitted.

Afemale thread88 is formed on the inner circumferential surface of thelock nut8. Thefemale thread88 extends in a region from the upper end to the substantially middle of the inner circumferential surface of thelock nut8. A portion of the inner circumferential surface of thelock nut8 that is located below thefemale thread88 constitutes acylindrical surface85 having a constant internal diameter. A position-restrictingprojection87 extending in the circumferential direction protrudes from thecylindrical surface85. A pair ofguide passages86 cut across the position-restrictingprojection87. Theguide passages86 extend in the vertical direction. Theguide passages86 divide the position-restrictingprojection87 in the circumferential direction.

It is preferable that thelock nut8 is made of a hard material. Specifically, a resin material such as polyacetal, polycarbonate, polystyrene, polyamide, polypropylene, or rigid polyvinyl chloride may be used. The lock nut120 can be integrally produced as a single component through injection molding or the like using such a resin material.

2.3. Assembling of Screw Lock Connector

As shown inFIG. 1, aflexible tube9 is passed through thelock nut8. Then, the connectingportion79 of the luermain body7 is inserted into the upper end of thetube9. Subsequently, thelock nut8 is moved upward. The luermain body7 is inserted into the inside of thefemale thread88 of thelock nut8. The protrudingportions76 that protrudes from the outer circumferential surface of the luermain body7 may possibly collide with the position-restrictingprojection87 that protrudes from the inner circumferential surface of thelock nut8. If this is the case, thelock nut8 is slightly rotated relative to the luermain body7. When the positions of the protrudingportions76 of the luermain body7 with respect to the circumferential direction coincide with the positions of therespective guide passages86 of thelock nut8 with respect to the circumferential direction, the protrudingportions76 can pass through theguide passages86. In this manner, thescrew lock connector6 can be assembled as shown inFIGS. 7A and 7B.

As shown inFIG. 7B, the position-restrictingprojection87 of thelock nut8 is located between theannular projection77 and the protrudingportions76 of the luermain body7. Due to the position-restrictingprojection87 colliding with theannular projection77 and the protrudingportions76, thelock nut8 is restricted from moving upward (toward the male luer72) and downward (toward the connecting portion79) relative to the luermain body7. However, thelock nut8 can freely rotate around the luermain body7.

3. Connection of Male Connector and Screw Lock Connector

The male connector1 (FIGS. 4A to 4C) and the screw lock connector6 (FIGS. 7A and 7B) can be connected to each other by inserting themale luer72 of the luermain body7 into thetubular portion17 of the connectormain body2 and screwing thefemale thread88 of thelock nut8 onto themale thread18 of thetubular portion17.

FIG. 8A is a side view showing a state in which themale connector1 and thescrew lock connector6 are connected to each other, andFIG. 8B is a cross-sectional view showing this state.

The outercircumferential surface72aof themale luer72 and the innercircumferential surface17aof thetubular portion17 are tapered surfaces having the same diameter and taper angle. Accordingly, as shown inFIG. 8B, the outercircumferential surface72aand the innercircumferential surface17acome into intimate contact with each other in a liquid-tight manner. Thus, thetube9 and theflow channel11 of themale luer10 are in communication with each other.

Thefemale thread88 of thelock nut8 and themale thread18 of thetubular portion17 are screwed together. Moreover, the position-restrictingprojection87 of thelock nut8 and theannular projection77 of the luermain body7 are engaged with each other. Thus, themale luer72 and thetubular portion17 are securely connected to each other. Even when an unintentional pull force acts between the male connector1 (or the connector main body2) and the screw lock connector6 (or the luer main body7), themale connector1 and thescrew lock connector6 will not be disconnected from each other.

As shown inFIG. 8A, thelock nut8 is disposed between the pair of operatingportions35. It is possible to rotate thelock nut8 while using theribs83, which are formed on the outer circumferential surface of thelock nut8, as an anti-slipping structure, to screw or unscrew thefemale thread88 onto or from themale thread18.

4. Female Connector

Themale connector1 is used by being connected to a female connector.FIGS. 9A and 9B show an example of the female connector.FIG. 9A is a perspective view of thefemale connector800, andFIG. 9B is a cross-sectional view of thefemale connector800.

Thefemale connector800 includes a disk-like partition member (hereinafter referred to as “septum”)810 as well as amount820 and acap830 that sandwich and fix theseptum810 in the vertical direction.

A straight line-shaped slit (cut portion)811 penetrating theseptum810 in the vertical direction is formed at the center of theseptum810. The material for theseptum810 is not limited, but a soft material having rubber elasticity is preferable, and for example, isoprene rubber, silicone rubber, butyl rubber, a thermoplastic elastomer, and the like can be used.

Themount820 includes, in the upper portion thereof, aseat821 having a substantially cylindrical shape. The outer circumferential surface of theseat821 is a cylindrical surface. A pair ofengagement claws822 and anannular projection823 protrude outward form the outer circumferential surface of theseat821. Theannular projection823 is slightly spaced downward from theengagement claws822.

Amale luer827 that is in communication with acavity825 of the seat221 and afemale thread828 that is coaxial with themale luer827 are provided below theseat821. The outer circumferential surface of themale luer827 is a male tapered surface (conical surface) whose external diameter gradually decreases toward the leading end (i.e., the external diameter decreases as the distance from theseat821 increases).

Thecap830 includes atop plate831 having a disk shape, and aperipheral wall835 extending downward from the outer circumferential end edge of thetop plate831 and having a cylindrical shape. A circular opening (through hole)832 is formed at the center of thetop plate831. A pair ofengagement holes836 are formed in theperipheral wall835. The engagement holes836 are through holes that penetrate theperipheral wall835 in the radial direction.

As shown inFIG. 9B, theseptum810 is placed on the upper end of theseat821, and theseptum810 is covered with thecap830 from above. Theengagement claws822 formed on theseat821 are fitted in the respective engagement holes836 formed in thecap830, and thus thecap830 is engaged with theengagement claws822. As a result, thecap830 is fixed to the mount820 (seeFIG. 9A). Theseptum810 is sandwiched between the upper end of theseat821 and thetop plate831 of thecap830 in the thickness direction (i.e., vertical direction). Theslit811 of theseptum810 is exposed in theopening832 that is formed in thetop plate831. Theannular projection823 formed on themount820 is located below and adjacent to theperipheral wall835 of thecap830. A top surface of theannular projection823 constitutes a cylindrical surface that is substantially the same as the outer circumferential surface of theperipheral wall835.

Thefemale connector800 including theseptum810 in which theslit811 is formed is generally called a needleless port (see, e.g., Patent Document 6).

5. Connection and Disconnection of Male Connector and Female Connector, and Method for Using the Same

Themale connector1 and thefemale connector800 constitute a coupling portion of an extracorporeal circuit. Themale connector1 and thefemale connector800 can be connected to each other in the following manner.

First, as shown inFIG. 10, themale connector1 and thefemale connector800 are located opposite to each other. Although not shown in the drawings, a flexible tube is connected to themale luer827 of thefemale connector800 directly or indirectly via a certain member.

From the state shown inFIG. 10, thecap830 of thefemale connector800 is inserted into thehood20 of themale connector1, and is pushed inward.

Anouter end edge830a(seeFIGS. 9A and 9B) of thetop plate831 of thecap830 abuts against theinclined surfaces32a(seeFIGS. 2E, 2F, 4A, and 4B) of theclaws32 of thelevers30. When thefemale connector800 is pushed further into thehood20, theend edge830aelastically displaces (swings) thelevers30 so that theclaws32 move away from themale luer10.

In parallel with this, the leadingend10a(seeFIG. 4A) of themale luer10 abuts against the septum810 (seeFIG. 9A) that is exposed in theopening832 of thecap830, and subsequently advances into theslit811 of theseptum810. Almost simultaneously, thehead portion41 of thecover4 abuts against theseptum810 or thetop plate831 of thecap830. As themale luer10 advances further into theseptum810, thecover4 is compressed in the vertical direction, and the outercircumferential wall45 is deformed so that its vertical dimension is reduced.

Theclaws32 of thelevers30 slide sequentially on theperipheral wall835 of thecap830 and theannular projection823. After theclaws32 have passed theannular projection823, thebase15 of the connectormain body2 elastically recovers, and theclaws32 are engaged with the annular projection823 (i.e., the locked state). Thus, the connection between themale connector1 and thefemale connector800 is completed.FIG. 11A is a perspective view showing this state.FIG. 11B is a cross-sectional view of the state.

As shown inFIG. 11B, themale luer10 penetrates the slit811 (seeFIGS. 9A and 9B) of theseptum810, and thus theseptum810 is deformed toward thecavity825 of theseat821. The openings of the lateral holes12 of themale luer10 are exposed in thecavity825 of theseat821. Therefore, theflow channel11 of themale luer10 and thecavity825 of theseat821 are in communication with each other. In this state, a liquid is allowed to flow from thetube9 to theflow channel71 of the luermain body7, theflow channel11 of themale luer10, thecavity825 of theseat821, and themale luer827, or in the reverse direction.

Thecover4 receives the compressive force in the vertical direction. In particular, the outercircumferential wall45 of thecover4 is deformed so that its vertical dimension is reduced.

Themale connector1 and thefemale connector800 can be disconnected from each other in the following manner. A force F (seeFIG. 2F) is applied to a pair of operatingportions35 in the direction in which they come close to each other, so that thelevers30 are pivoted to release the engagement of theclaws32 with theannular projection823. In this state, when themale connector1 and thefemale connector800 are pulled apart from each other, themale connector1 and thefemale connector800 can be disconnected from each other (seeFIG. 10). Theseptum810 elastically recovers immediately after the removal of themale luer10, and thus theslit811 is closed. Thecover4 expands and returns to the initial state due to its elastic recovery force, and the inner circumferential surface of thehead portion42 closes the openings of the lateral holes12 of the male luer10 (seeFIGS. 4B, 4C, and 8B). Thelevers30 elastically return to the initial state upon release of the external force applied to the operatingportions35.

The extracorporeal circuit for circulating blood includes a blood removal line and a reinfusion line. The blood removal line is used to remove blood from the vein of a patient, and the reinfusion line is used to return blood back to the vein of the patient. For example, in the extracorporeal circuit for hemodialysis, blood is transferred from a patient to a dialyzer via the blood removal line, and then blood is returned from the dialyzer to the patient via the reinfusion line. The blood removal line and the reinfusion line each have a coupling portion including themale connector1 and thefemale connector800, as described above. For example, in both the blood removal line and the reinfusion line, the opposite end of the tube9 (seeFIGS. 1 and 11A) to themale connector1 may be connected to the vein of the patient. The male luer827 (seeFIG. 11A) of thefemale connector800 may be connected to the dialyzer via a tube (not shown). A pump for circulating blood may be provided on thetube9 that constitutes, e.g., the blood removal line.

As described above, when themale connector1 and thefemale connector800 are connected to each other (seeFIGS. 11A and 11B), theflow channel11 of themale luer10 and thecavity825 of theseat821 are in communication with each other. Therefore, blood can flow through themale connector1 and thefemale connector800.

Theclaws32 of themale connector1 are engaged with thefemale connector800 while themale connector1 and thefemale connector800 are being connected to each other. Therefore, even if an external force is applied, e.g., in the direction in which themale connector1 and thefemale connector800 are disconnected from each other during blood circulation, themale connector1 and thefemale connector800 will not be unintentionally disconnected from each other.

When themale connector1 and thefemale connector800 are disconnected from each other, thecover4 of themale connector1 immediately returns to the initial state and closes the lateral holes12 of themale luer10. Moreover, theseptum810 of thefemale connector800 immediately returns to the initial state, so that theslit811 is closed. Thus, even if themale connector1 and thefemale connector800 are unintentionally disconnected from each other during blood circulation, there is a low probability that blood will leak from themale connector1 and thefemale connector800.

As described above, a priming operation needs to be performed before circulating blood in the extracorporeal circuit. The priming operation introduces a priming fluid into the extracorporeal circuit and discharges air in the extracorporeal circuit to the outside. The priming operation is performed before connecting themale connector1 to thefemale connector800. As can easily be seen fromFIG. 8B, when themale connector1 is not connected to the female connector800 (i.e., the initial state), thecover4 closes the lateral holes12 of themale luer10 of themale connector1. Therefore, in this state, the priming fluid cannot be introduced into thetube9, theflow channel71 of the luermain body7, and theflow channel11 of themale luer10. If themale connector1 and thescrew lock connector6 are disconnected from each other, the priming fluid can be introduced into thetube9 and theflow channel71 of the luermain body7, but still cannot be introduced into theflow channel11 of themale luer10.

The adapter of the present invention is attached to themale connector1 to facilitate the introduction of the priming fluid into themale connector1. Hereinafter, the adapter of the present invention will be described.

Embodiment 1

1. Configuration of Adapter

FIG. 12A is a perspective view of anadapter100 according toEmbodiment 1 of the present invention when viewed from afirst end portion101 of theadapter100.FIG. 12B is a perspective view of theadapter100 when viewed from asecond end portion102 of theadapter100.FIG. 12C is a side view of theadapter100.FIG. 12D is a cross-sectional perspective view of theadapter100. InFIG. 12D, an alternate long andshort dash line100arepresents a central axis of theadapter100 joining thefirst end portion101 and thesecond end portion102. For the sake of convenience of the following description, the direction that is orthogonal to thecentral axis100ais referred to as a “radial direction” or a “diameter direction”, and the direction of rotation about thecentral axis100ais referred to as a “circumferential direction”. With respect to the radial direction, the side nearer thecentral axis100ais referred to as the “inner side”, and the side further from thecentral axis100ais referred to as the “outer side”.

As shown inFIG. 12D, theadapter100 has a through hole (flow channel)103 that penetrates theadapter100 along thecentral axis100a. The throughhole103 is open in both thefirst end portion101 and thesecond end portion102 of theadapter100, and allows thefirst end portion101 to be in communication with thesecond end portion102. As will be described later, when the priming operation is performed on themale connector1 with theadapter100 attached to themale connector1, a priming fluid flows through the throughhole103.

Thefirst end portion101 includes a hollowtubular portion110 that is coaxial with thecentral axis100a. The throughhole103 penetrates thetubular portion110. Afirst projection111 and asecond projection112 are provided on the outer circumferential surface of thetubular portion110. Alarge diameter portion105 is provided on abase end113 of thetubular portion110.

Both thefirst projection111 and thesecond projection112 are annular projections that continuously extend in the circumferential direction. Thefirst projection111 is located on the leading end side of thetubular portion110. Thesecond projection112 is located on thebase end113 side (i.e., on the side facing the large diameter portion105) of thetubular portion110 with respect to thefirst projection111. Thefirst projection111 is spaced apart from thesecond projection112, and an annular groove (recessed portion) continuously extending in the circumferential direction is formed between thefirst projection111 and thesecond projection112. Moreover, thesecond projection112 is spaced apart from thelarge diameter portion105, and an annular groove (recessed portion) continuously extending in the circumferential direction is formed between thesecond projection112 and thelarge diameter portion105. The outer circumferential surface of thefirst projection111 and the outer circumferential surface of thesecond projection112 constitute cylindrical surfaces that are coaxial with thecentral axis100aand have the same radius. The external diameter of thefirst projection111 and the external diameter of thesecond projection112 are approximately equal to the external diameter of the female connector800 (i.e., the external diameter of theperipheral wall835 of thecap830 and the external diameter of theannular projection823, seeFIG. 9A) that is connected to themale connector1 to which theadapter100 is to be attached.

The outer circumferential surface of thefirst projection111 and the outer circumferential surface of thesecond projection112 do not have to be cylindrical surfaces. For example, the cross-sectional shape of each of thefirst projection111 and thesecond projection112 in the cross section containing thecentral axis100amay be in the form of a triangle, arc, or the like. In this case, however, thefirst projection111 and thesecond projection112 are preferably annular projections that continuously extend in the circumferential direction. Thus, theclaws32 can be engaged with thefirst projection111 and thesecond projection112 regardless of the position of theadapter100 in the direction of rotation relative to themale connector1, as will be described later.

Thesecond projection112 has a taperedsurface112aon the end edge thereof facing thefirst projection111. Thetapered surface112ais a conical surface whose external diameter gradually decreases toward thefirst projection111.

Thelarge diameter portion105 protrudes outward in the radial direction compared to thefirst projection111 and thesecond projection112. The external diameter of thelarge diameter portion105 is preferably equal to or slightly larger than the external diameter of thehood20 of themale connector1 at theleading end20a(seeFIG. 2A). In this embodiment, thelarge diameter portion105 has a substantially disk shape (so-called flange shape), but the present invention is not limited thereto. For example, a substantially elliptical shape may be divided in the circumferential direction by one or more notches formed along the radial direction. In this embodiment, thelarge diameter portion105 is circular when viewed along thecentral axis100a. The shape of thelarge diameter portion105 may be other than this, e.g., an approximate ellipse, a triangle, a rectangle, or a hexagon. Moreover, thelarge diameter portion105 may be in the form of one or more projections (e.g., plate-shaped projections, rod-shaped projections, or dome-shaped projections) that protrude from thebase end113 in the radial direction.

As shown inFIG. 12D, the inner circumferential surface of thetubular portion110 defines the throughhole103 and includes afirst region116, asecond region117, and athird region118 that are arranged in the direction from thebase end113 to the leading end of thetubular portion110. Thefirst region116, thesecond region117, and thethird region118 are coaxial with thecentral axis100a, and the internal diameter increases in the indicated order. The internal diameter of thesecond region117 is larger than the external diameter of the head portion41 (seeFIG. 3A) of thecover4. The internal diameter of thefirst region116 is smaller than the external diameter of theheat portion41 of thecover4.

In this embodiment, the inner circumferential surface of thefirst region116 is a tapered surface (conical surface) whose internal diameter gradually decreases toward thebase end113. The inner circumferential surfaces of thesecond region117 and thethird region118 are cylindrical surfaces. However, the present invention is not limited thereto. For example, the inner circumferential surface of thefirst region116 may be a cylindrical surface, and one or both of thesecond region117 and thethird region118 may have an inner circumferential surface that is a tapered surface (conical surface) whose internal diameter gradually decreases toward thebase end113. The inner circumferential surface of thetubular portion110 may include another region with an internal diameter that is different from those of thefirst region116, thesecond region117, and thethird region118. Alternatively, one or both of thesecond region117 and thethird region118 may be omitted.

Ashoulder portion119 is formed between thefirst region116 and thesecond region117. Theshoulder portion119 is based on the difference in the internal diameter between thefirst region116 and thesecond region117. Theshoulder portion119 is a plane perpendicular to thecentral axis100a. Anannular rib119acontinuously extends in the circumferential direction and protrudes from theshoulder portion119 toward the leading end of thetubular portion110. Theannular rib119ais a cylindrical projection that is formed along the inner circumferential end edge of theshoulder portion119 and is coaxial with thecentral axis100a. Theannular rib119ais spaced apart from the inner circumferential surface of thesecond region117 in the radial direction. The internal diameter of theannular rib119ais larger than the external diameter of themale luer10, smaller than the external diameter of the head portion41 (seeFIG. 3A) of thecover4, and approximately equal to or slightly larger than the external diameter of theprotrusion44 that protrudes from thehead portion41.

Thesecond end portion102 of theadapter100 includes amale luer121 having a tubular shape and anouter cylinder125 that surrounds themale luer121. An outercircumferential surface122 of themale luer121 is a tapered surface (so-called male tapered surface) whose external diameter gradually decreases toward the leading end. The throughhole103 penetrates themale luer121. A female thread (screw structure)126 is formed on the inner circumferential surface of theouter cylinder125 that faces themale luer121. A plurality ofribs127 extending parallel to thecentral axis100aare provided on the outer circumferential surface of theouter cylinder125. Themale luer121 and thefemale thread125 may comply with a lock connector defined by ISO594-2.

It is preferable that the adapter1002 is made of a hard material. Specifically, a resin material such as polyacetal, polycarbonate, polystyrene, polyamide, polypropylene, or rigid polyvinyl chloride may be used. Theadapter100 can be integrally produced as a single component through injection molding or the like using such a resin material.

In this embodiment, theouter cylinder125 is provided on the surface of thelarge diameter portion105 that is on the same side as thesecond end portion102. However, theouter cylinder125 may be spaced apart from thelarge diameter portion105 in the direction of thecentral axis100a. In this case, themale luer121 is also spaced apart from thebase end113 of thetubular portion110 in the direction of thecentral axis100a. Thebase end113 of thetubular portion110 and themale luer121 are coupled with a hollow member in which the throughhole103 is provided.

2. Method for Using Adapter

2.1 Connection of Adapter to Male Connector at First Position

Theadapter100 is connected to themale connector1 before performing the priming operation on themale connector100. This will be described below.

First, as shown inFIG. 13, the first end portion101 (the tubular portion110) of theadapter100 is located opposite to themale connector1. Thescrew lock connector6 and thetube9 have not been connected to themale connector1 at this stage.

From the state shown inFIG. 13, thefirst end portion101 is connected to themale connector1. Specifically, thetubular portion110 of theadapter100 is inserted into thehood20 of themale connector1, and is pushed inward. Anend edge111a(seeFIG. 12A) at the leading end of thefirst projection111 of theadapter100 abuts against theinclined surfaces32a(seeFIGS. 2E, 2F, 4A, and 4B) of theclaws32 of thelevers30. When theadapter100 is pushed further into thehood20, theend edge111aelastically displaces (swings) thelevers30 so that theclaws32 move away from themale luer10. Subsequently, when theadapter100 is pushed further into thehood20, theclaws32 slide on thefirst projection111 of theadapter100. After theclaws32 have passed thefirst projection111, thebase15 of the connectormain body2 elastically recovers, and theclaws32 are fitted in the annular groove that is formed between thefirst projection111 and thesecond projection112 of theadapter100 and continuously extends in the circumferential direction.

FIG. 14A is a perspective view showing this state.FIGS. 14B and 14C are cross-sectional views of the state. The cross section inFIG. 14B is the same as that inFIG. 4B. The cross section inFIG. 14C is the same as that inFIG. 4C.

As shown inFIG. 14B, theclaws32 of themale connector1 are engaged with thefirst projection111 of theadapter100. Therefore, themale connector1 and theadapter100 cannot be disconnected from each other only by pulling them in opposite directions. However, when a force F (seeFIG. 2F) is applied to a pair of operatingportions35 in the direction in which they come close to each other, the engagement of theclaws32 with thefirst projection111 is released, and theadapter100 can be disconnected from themale connector1. In the present invention, the position of theadapter100 relative to themale connector1 in which theadapter100 is connected to themale connector1 with theclaws32 being engaged with thefirst projection111 is referred to as a “first position”.

As shown inFIGS. 14B and 14C, thehead portion41 of thecover4 is inserted into thesecond region117 of theadapter100. The annularupper surface43 of thehead portion41 is spaced apart from theannular rib119ain the vertical direction and faces theannular rib119a. As is best shown inFIG. 14B, the rib-shapedprojections46 that protrude from the outer circumferential surface of the outercircumferential wall45 of thecover4 are housed in thethird region118 of theadapter100. Thecover4 is spaced apart from or merely in contact with theadapter100. Therefore, theadapter100 exerts substantially no force on thecover4. The shape of thecover4 is substantially the same as that in the initial state (seeFIGS. 4A to 4C). The openings of the lateral holes12 of themale luer10 are closed off by the inner circumferential surface of the throughhole42 of thecover4. Theflow channel11 of themale luer10 is sealed with thehead portion41 of thecover4. Thus, theflow channel11 of themale luer10 is not in communication with the throughhole103 of theadapter100.

Thelarge diameter portion105 is spaced apart from the leadingend20aof thehood20 in the vertical direction.

Themale connector1 and theadapter100 are sterilized and packaged in a state in which theadapter100 is connected to themale connector1 at the first position (seeFIGS. 14A to 14C). The sterilization and packaging processes may be carried out by manufacturers and distributors of themale connector1. Themale connector1 provided with theadapter100, which have been sterilized and packaged, are delivered and stored in medical institutions such as hospitals. The sterilization and packaging processes are not particularly limited, and may be the same as those generally performed on the conventional male connector.

When theadapter100 is in the first position, thecover4 is not substantially deformed and remains its initial shape. Therefore, even if themale connector1 to which theadapter100 is connected at the first position is stored for a long period of time, the elastic recovery force of the outercircumferential wall45 of thecover4 will not be reduced.

When theadapter100 is in the first position, theclaws32 are engaged with thefirst projection111. Therefore, even if themale connector1 is subjected to vibration, an external force, or the like during transport, there is a low probability that themale connector1 and theadapter100 will be disconnected from each other.

2.2 Preparation for Priming

When an extracorporeal circuit is formed in medical institutions, the package containing themale connector1 and theadapter100 is torn open, and the male connector1 (seeFIGS. 14A to 14C) to which theadapter100 is connected at the first position is taken out.

The screw lock connector6 (seeFIGS. 7A and 7B) is attached to the distal end of thesoft tube9 that constitutes each of the blood removal line and the reinfusion line in the extracorporeal circuit. As shown inFIG. 15, themale connector1 is connected to thescrew lock connector6. Theadapter100 is still in the first position relative to themale connector1.

Next, theadapter100 is pushed toward themale connector1. As shown inFIG. 14B, when theadapter100 is in the first position, thetapered surface112a(seeFIG. 12A) provided on thesecond projection112 of theadapter100 faces theinclined surfaces32a(seeFIGS. 2E, 2F, 4A, and 4B) of theclaws32 of thelevers30. When theadapter100 is pushed into thehood20, thetapered surface112aelastically displaces (swings) thelevers30 so that theclaws32 move away from themale luer10. Subsequently, when theadapter100 is pushed further into thehood20, theclaws32 slide on thesecond projection112 of theadapter100. After theclaws32 have passed thesecond projection112, thebase15 of the connectormain body2 elastically recovers, and theclaws32 are fitted in the annular groove that is formed between thesecond projection112 and thelarge diameter portion105 of theadapter100 and continuously extends in the circumferential direction.

FIG. 16A is a perspective view showing this state.FIGS. 16B and 16C are cross-sectional views of the state. The cross section inFIG. 16B is the same as that inFIGS. 4B and 14B. The cross section inFIG. 16C is the same as that inFIGS. 4C and 14C.

As shown inFIG. 16B, theclaws32 of themale connector1 are engaged with thesecond projection112 of theadapter100. Therefore, similarly to the state in which theadapter100 is in the first position, themale connector1 and theadapter100 cannot be disconnected from each other only by pulling them in opposite directions. In the present invention, the position of theadapter100 relative to themale connector1 in which theadapter100 is connected to themale connector1 with theclaws32 being engaged with thesecond projection112 is referred to as a “second position”.

As described above, thetapered surface112ais formed on the end edge of thesecond projection112 that faces thefirst projection111. Therefore, an operator is required to simply push theadapter100 into themale connector1, so that the state of engagement of theclaws32 with the first projection111 (seeFIGS. 14A to 14C) can easily be shifted to the state of engagement of theclaws32 with the second projection112 (seeFIGS. 16A to 16C).

As shown inFIG. 16C, theprotrusion44 of thehead portion41 of thecover4 is fitted in thefirst region116 of theadapter100. Theannular rib119athat protrudes from theshoulder portion119 of theadapter100 abuts against theupper surface43 of thehead portion41. Theannular rib119apresses theupper surface43 downward. Consequently, the outercircumferential wall45 of the cover40 is elastically and compressively deformed in the vertical direction.

Themale luer1 penetrates thehead portion41 and is inserted into thefirst region116 while thehead portion41 of thecover4 is abutting against theannular rib119a. The leadingend10aof themale luer10 protrudes over thehead portion41, and the lateral holes12 of themale luer10 are exposed in thefirst region116. Thus, theflow channel11 of themale luer10 is in communication with the throughhole103 of theadapter100.

Theannular rib119aof theadapter100 and theupper surface43 of thehead portion41 of thecover4 are pressed against each other in the vertical direction to form a liquid-tight seal between them. The contact area between the leading end of theannular rib119aand theupper surface43 of thehead portion41 is very small, so that the sealing between them can be improved.

As shown inFIGS. 16B and 16C, thefirst projection111 and thesecond projection112 of theadapter100 are inserted into thehood20 of themale connector1. Thelarge diameter portion105 protrudes outside thehood20 in the radial direction, and abuts against the leadingend20aof thehood20 in the vertical direction. Therefore, thelarge diameter portion105 prevents theadapter100 from being further inserted into thehood20 to a depth deeper than the second position. This is advantageous in preventing damage to thecover4 due to excessive deformation caused by theadapter100.

2.3 Priming

Since theadapter100 has been moved to the second position (seeFIGS. 16A to 16C), the lateral holes12 of themale luer10 are open. Therefore, a priming fluid can be introduced into themale connector1. The method for introducing the priming fluid may be selected as desired.

The priming operation inEmbodiment 1 preferably uses adrain connector150 shown inFIGS. 17A and 17B.FIG. 17A is a perspective view of thedrain connector150.FIG. 17B is a cross-sectional view of thedrain connector150.

Thedrain connector150 includes atubular portion151 having a hollow cylindrical shape. As shown inFIG. 17A, anarm155 and ahandle157 protrude from the outer circumferential surface of thetubular portion151. Thearm155 has a cantilever structure with one end (fixed end) being fixed to thetubular portion151. Thearm155 is bent in a substantially “L” shape so that thearm155 and thetubular portion151 can form a substantially triangle. The other end (free end)155aof thearm155 is close to thetubular portion151. Thehandle157 has a substantially “U” shape, and both ends are fixed to thetubular portion151.Male threads153a,153bare provided on both ends of thetubular portion151, respectively.

As shown inFIG. 17B, thetubular portion151 has a through hole (flow channel)152 that connects one end to the other. Portions of the inner circumferential surface of the throughhole152 that are near both ends of thetubular portion151 constitute tapered surfaces (so-called female tapered surfaces)154a,154bwhose internal diameters gradually increase toward the respective ends of thetubular portion151.

The firstmale thread153aand the first female taperedsurface154athat are provided on one end of thetubular portion151 and the secondmale thread153band the second female taperedsurface154bthat are provided on the other end of thetubular portion151 are both fitted to thefemale thread126 and the outer circumferential surface (male tapered surface)122 of themale luer121 of theadapter100. For example, themale threads153a,153band the female taperedsurfaces154a,154bmay comply with a lock connector defined by ISO594-2.

Hereinafter, two typical priming methods using thedrain connector150 will be described.

[First Priming Method]

FIGS. 18A and 18B are a perspective view and a cross-sectional view for explaining a first priming method, respectively. As shown inFIGS. 18A and 18B, the drain connector150 (seeFIGS. 17A and 17B) is attached to the adapter100 (seeFIGS. 16A to 16C) that is connected to themale connector1 at the second position. Specifically, themale luer121 of theadapter100 is inserted into the throughhole152 of thedrain connector150, and themale thread153aof thedrain connector150 is screwed into thefemale thread126 of theadapter100. The female taperedsurface154aof thedrain connector150 and the male tapered surface of the outercircumferential surface122 of themale luer121 have the same diameter and taper angle. Therefore, themale luer121 and thetubular portion151 of thedrain connector150 are connected to each other in a liquid-tight manner.

Thedrain connector150 is fixed to a container for collecting a priming fluid with the end of thedrain connector150 that is not connected to the adapter100 (i.e., the end on which themale thread153bis formed) facing downward. For example, the container has an opening that is open upward, and the upper end of the wall of the container surrounding the opening may be sandwiched between thefree end155aof thearm155 and thetubular portion151, so that thedrain connector150 can be attached to the wall of the container. In this state, a priming fluid is introduced from thetube9. The priming fluid flows through thetube9, theflow channel71 of the luermain body7, theflow channel11 of themale luer10, the throughhole103 of theadapter100, and the throughhole152 of thedrain connector150 in sequence, and then enters the container. When the priming fluid flows into these members, air that has been present in the members is discharged through thedrain connector150 to the outside. As described above, since a liquid-tight seal is formed between theannular rib119aof theadapter100 and theupper surface43 of the cover4 (seeFIG. 16C), the priming fluid will not leak between them.

After a series of members from thetube9 to thedrain connector150 are filled with the priming fluid, thetube9 is squeezed by, e.g., a clamp (not shown) to close the flow channel. Then, a force F (seeFIG. 2F) is applied to a pair of operatingportions35 of themale connector1 in the direction in which they come close to each other, so that thelevers30 are pivoted to release the engagement of theclaws32 with thesecond projection112. In this state, when themale connector1 and theadapter100 are pulled apart from each other, theadapter100 to which thedrain connector150 is attached can be disconnected from themale connector1. Once theadapter100 is removed, thecover4 immediately expands and returns to the initial state (seeFIG. 8B) due to its elastic recovery force, and the inner circumferential surface of thehead portion42 closes the openings of the lateral holes12 of themale luer10. Therefore, the priming fluid filled in theflow channel11 and the lateral holes12 of themale luer10 will not leak to the outside. Thelevers30 elastically return to the initial state upon release of the external force applied to the operatingportions35.

Consequently, the priming operation is finished. The above priming operation is performed on each of the blood removal line and the reinfusion line in the extracorporeal circuit.

Thereafter, as described above, themale connector1 is connected to the female connector800 (seeFIGS. 11A and 11B) to form an extracorporeal circuit. Another priming operation for thefemale connector800 and the tube connected thereto has been completed.

As described above, the priming fluid can be introduced into themale connector1 while theadapter100 is being connected to themale connector1 at the second position.

Theadapter100 can be connected to themale connector1 at two positions, i.e., the first position and the second position. Theadapter100 has been connected to themale connector1 at the first position and sterilized before they are delivered to medical institutions such as hospitals. In medical institutions, theadapter100 in the first position is pushed into themale connector1 and shifted to the second position immediately before performing the priming operation. The priming operation is made possible only by pushing theadapter100 into themale connector1. It is not necessary to attach theadapter100 to themale connector1. Thus, the operation is very simple. Moreover, theadapter100 does not have to be previously prepared and stored separately from themale connector1.

Since theadapter100 has previously been connected to themale connector1 at the first position, there is a very low probability that bacteria will enter theflow channel11 of themale luer10 because of the attachment of theadapter100 to themale connector1.

Therefore, the use of theadapter100 can easily and hygienically introduce the priming fluid into themale luer10 of the lever lockmale connector1 having thecover4.

When theadapter100 is connected to themale connector1 at the first position, thecover4 is not substantially deformed and remains in the initial state. Therefore, even if themale connector1 to which theadapter100 is connected at the first position is allowed to stand for a long period of time, the elastic recovery force of the outercircumferential wall45 of thecover4 will not be reduced. This is advantageous in ensuring the function of thecover4 that immediately returns to the initial state and closes the flow channel of themale luer10 even if themale connector1 is unintentionally disconnected from thefemale connector800 during extracorporeal circulation.

By utilizing thedrain connector150 connected to thesecond end portion102 of theadapter100, theadapter100 and themale connector1 can be stably fixed to the container into which the priming fluid is to be discharged.

In the first priming method, theadapter100 is connected to one end of thedrain connector150 on which themale thread153ais provided. Theadapter100 may also be connected to the other end of thedrain connector150 on which themale thread153bis provided. The priming fluid is also allowed to flow from themale luer121 of theadapter100 without using thedrain connector150.

[Second Priming Method]

FIG. 19 is a perspective view showing a state immediately before performing a second priming method. In the second priming method, two sets of themale connector1 to which theadapter100 is connected at the second position, as shown inFIGS. 16A to 16C, are prepared. The following description refers to the drawings in which the members that are located on both sides of thedrain connector150 are distinguished by marking the members that are on the same side as themale thread153bwith an apostrophe (′). The members marked with an apostrophe (′) are the same as those denoted by the same reference numerals without an apostrophe (′).

For example, themale connector1 and thetube9 connected to themale connector1 may constitute the blood removal line in the extracorporeal circuit. On the other hand, themale connector1′ and thetube9′ connected to themale connector1′ may constitute the reinfusion line in the extracorporeal circuit.

Next, as shown inFIG. 20A theadapter100 connected to themale connector1 is connected to one end of thedrain connector150 having themale thread153a, and theadapter100′ connected to themale connector1′ is connected to the other end of thedrain connector150 having themale thread153b.FIG. 20B is a cross-sectional view ofFIG. 20A Themale thread153aand the female taperedsurface154aof thedrain connector150 are fitted to thefemale thread126 and the male taperedsurface122 of theadapter100. Themale thread153band the female taperedsurface154bof thedrain connector150 are fitted to thefemale thread126′ and the male taperedsurface122′ of theadapter100′. Therefore, themale luer121, thedrain connector150, and themale luer121′ are connected to one another in a liquid-tight manner.

In this state, a priming fluid is introduced from thetube9. The priming fluid flows through thetube9, theflow channel71 of the luermain body7, theflow channel11 of themale luer10, the throughhole103 of theadapter100, the throughhole152 of thedrain connector150, the throughhole103′ of theadapter100′, theflow channel11′ of themale luer10′, theflow channel71′ of the luermain body7′, and thetube9′ in sequence, and then exits from the distal end (not shown) of thetube9′ to the outside. When the priming fluid flows into these members, air that has been present in the members is discharged through the distal end of thetube9′ to the outside.

After a series of members from thetube9 at one end to thetube9′ at the other end are filled with the priming fluid, thetubes9,9′ are squeezed by, e.g., clamps (not shown) to close their respective flow channels. Then, a force F (seeFIG. 2F) is applied to a pair of operatingportions35 of themale connector1 in the direction in which they come close to each other, so that thelevers30 are pivoted to release the engagement (seeFIG. 16B) of theclaws32 with thesecond projection112. In this state, when themale connector1 and theadapter100 are pulled apart from each other, theadapter100 to which thedrain connector150 is attached can be disconnected from themale connector1. Once theadapter100 is removed, thecover4 immediately expands and returns to the initial state (seeFIG. 8B) due to its elastic recovery force, and the inner circumferential surface of thehead portion42 closes the openings of the lateral holes12 of themale luer10. Therefore, the priming fluid filled in theflow channel11 and the lateral holes12 of themale luer10 will not leak to the outside. Thelevers30 elastically return to the initial state upon release of the external force applied to the operatingportions35. Theadapter100′ is disconnected from themale connector1′ in the same manner as described above.

Consequently, the priming operation is finished.

Thereafter, as described above, themale connectors1,1′ are connected to different female connectors800 (seeFIGS. 11A and 11B) to form extracorporeal circuits, respectively. Another priming operation for thefemale connectors800 and the tubes connected thereto has been completed.

Similarly to the first priming method, the second priming method also uses theadapter100 and can easily and hygienically introduce the priming fluid into themale luer10 of the lever lockmale connector1 having thecover4. Even if themale connector1 to which theadapter100 is connected at the first position is allowed to stand for a long period of time, the elastic recovery force of the outercircumferential wall45 of thecover4 will not be reduced. This can ensure the function of thecover4.

Further, in the second priming method, themale connector1 and themale connector1′ are in communication with each other via thedrain connector150. Thus, the priming fluid can be simultaneously introduced into, e.g., themale connector1 for the blood removal line and themale connector1′ for the reinfusion line. Accordingly, the priming operation can be efficiently performed.

In the first and second priming methods, thedrain connector150 is connected to the adapter100 (100′) after the adapter100 (100′) has been shifted from the first position to the second position. However, the present invention is not limited thereto, and thedrain connector150 may be connected to the adapter100 (100′) that is in the first position (seeFIG. 15), and then the adapter100 (100′) may be shifted to the second position.

Embodiment 2

1. Configuration of Adapter

FIG. 21A is a perspective view of anadapter200 according toEmbodiment 2 of the present invention.FIG. 21B is a side view of theadapter200.FIG. 21C is a cross-sectional perspective view of theadapter200. InFIG. 21C, an alternate long andshort dash line200arepresents a central axis of theadapter200 joining afirst end portion201 and asecond end portion202. For the sake of convenience of the following description, the direction that is orthogonal to thecentral axis200ais referred to as a “radial direction” or a “diameter direction”, and the direction of rotation about thecentral axis200ais referred to as a “circumferential direction”. With respect to the radial direction, the side nearer thecentral axis200ais referred to as the “inner side”, and the side further from thecentral axis200ais referred to as the “outer side”.

As shown inFIG. 21C, similarly to theadapter100 inEmbodiment 1, theadapter200 has a through hole (flow channel)203 that penetrates theadapter200 along thecentral axis200a. The throughhole203 is open in both thefirst end portion201 and thesecond end portion202 of theadapter200, and allows thefirst end portion201 to be in communication with thesecond end portion202.

Theadapter200 inEmbodiment 2 is obtained by modifying the adapter100 (FIGS. 12A to 12D) inEmbodiment 1 so that the configuration provided on thesecond end portion102 side with respect to thelarge diameter portion105 is made the same as that provided on thefirst end portion101 side with respect to thelarge diameter portion105. In other words, thefirst end portion201 and thesecond end portion202 of theadapter200 inEmbodiment 2 have the same configuration as that of thefirst end portion101 of theadapter100 inEmbodiment 1. Theadapter200 is symmetrical with respect to thelarge diameter portion105 in the center. In theadapter200 inEmbodiment 2, the same components as those of theadapter100 inEmbodiment 1 are denoted by the same reference numerals, and a detailed description about them will not be repeated. However, in order to distinguish between the components on thefirst end portion201 side and the components on thesecond end portion202 side with respect to thelarge diameter portion105, the components on thesecond end portion202 side are marked with an apostrophe (′). The components marked with an apostrophe (′) are the same as those denoted by the same reference numerals without an apostrophe (′).

Theadapter200 can be integrally produced as a single component through injection molding or the like using the same material as that of theadapter100 inEmbodiment 1.

2. Method for Using Adapter

2.1 Connection of Adapter to Male Connector at First Position

In this embodiment,male connectors1 are connected to bothend portions201,202 of theadapter200.FIG. 22 is a perspective view showing a state immediately before connecting themale connectors1. The following description refers to the drawings in which the members that are located on both sides of theadapter200 are distinguished by marking the members that are on the same side as thesecond end portion202 with an apostrophe (′). The members marked with an apostrophe (′) are the same as those denoted by the same reference numerals without an apostrophe (′). As shown inFIG. 22, thescrew lock connector6 and thetube9 are not connected to themale connectors1,1′ at this stage.

From the state shown inFIG. 22, similarly toEmbodiment 1, thefirst end portion201 is connected to themale connector1 and thesecond end portion202 is connected to themale connector1′.FIG. 23A is a perspective view showing the connected state.FIGS. 23B and 23C are cross-sectional views ofFIG. 23A The cross section inFIG. 23B is the same as that inFIG. 4B. The cross section in FIG.23C is the same as that inFIG. 4C. Both the state of connection between thefirst end portion201 and themale connector1 and the state of connection between thesecond end portion201 and themale connector1′, as shown inFIGS. 23A to 23C, are the same as the state of connection between thefirst end portion101 and themale connector1 at the first position in Embodiment 1 (FIGS. 14A to 14C). Specifically, theclaws32,32′ of themale connectors1,1′ are engaged with thefirst projections111,111′ of theadapter200, respectively. Theflow channels11,11′ of themale luers10,10′ are sealed with thehead portions41,41′ of thecovers4,4′.

Themale connectors1,1′ and theadapter200 are sterilized and packaged in a state in which themale connectors1,1′ are connected to both ends of theadapter200 at the first position (seeFIGS. 23A to 23C). The sterilization and packaging processes may be carried out by manufacturers and distributors of themale connectors1,1′. Themale connectors1,1′ coupled together via theadapter200, which have been sterilized and packaged, are delivered and stored in medical institutions such as hospitals.

The same explanation given for the connection of theadapter100 to themale connector1 at the first position inEmbodiment 1 can also be applied toEmbodiment 2.

2.2 Priming

When an extracorporeal circuit is formed in medical institutions, the packaging containing themale connectors1,1′ and theadapter200 is torn open, and themale connectors1,1′ (seeFIGS. 23A to 23C) to which theadapter200 is connected at the first position is taken out.

As shown inFIG. 24, thescrew lock connectors6,6′ attached to the distal ends of thetubs9,9′ are connected to themale connectors1,1′, respectively. For example, thetube9 may constitute the blood removal line and thetube9′ may constitute the reinfusion line in the extracorporeal circuit. Theadapter200 is still in the first position relative to themale connectors1,1′.

Next, theadapter200 is pushed toward themale connectors1,1′. Specifically, while holding themale connector1 and themale connector1′, forces are applied to them in directions facing each other. Then, thelevers30 are displaced (swung) in the same manner as described inEmbodiment 1, so that theclaws32,32′ are fitted in the respective annular grooves that are formed between thesecond projections112,112′ and thelarge diameter portion105 of theadapter200 and continuously extend in the circumferential direction.

FIG. 25A is a perspective view showing this state.FIGS. 25B and 25C are cross-sectional views of the state. The cross section inFIG. 25B is the same as that inFIGS. 4B and 23B. The cross section inFIG. 25C is the same as that inFIGS. 4C and 23C. The state of connection between thefirst end portion201 and themale connector1 and the state of connection between thesecond end portion202 and themale connector1′, as shown inFIGS. 25A to 25C, are the same as the state of connection between thefirst end portion101 and themale connector1 at the second position in Embodiment 1 (FIGS. 16A to 16C). Specifically, theclaws32,32′ of themale connectors1,1′ are engaged with thesecond projections112,112′ of theadapter200, respectively. The outercircumferential walls45,45′ of the covers40,40′ are elastically and compressively deformed in the vertical direction. Theflow channels11,11′ of themale luers10,10′ are in communication with the throughhole203 of theadapter200. Liquid-tight seals are formed between theannular ribs119a,119a′ of theadapter200 and the upper surfaces of thehead portions41,41′ of thecovers4,4′, respectively.

The same explanation given for the connection of theadapter100 to themale connector1 at the second position inEmbodiment 1 can also be applied toEmbodiment 2.

Since theadapter200 has been moved to the second position (seeFIGS. 25A to 25C), the lateral holes12,12′ of themale luers10,10′ are open. Therefore, a priming fluid can be introduced into themale connectors1,1′.

The priming operation can be performed in the same manner as the second priming method inEmbodiment 1. In the state shown inFIGS. 25A to 25C, a priming fluid is introduced from thetube9. The priming fluid flows through thetube9, theflow channel71 of the luermain body7, theflow channel11 of themale luer10, the throughhole203 of theadapter200, theflow channel11′ of themale luer10′, theflow channel71′ of the luermain body7′, and thetube9′ in sequence, and then exits from the distal end (not shown) of thetube9′ to the outside. When the priming fluid flows into these members, air that has been present in the members is discharged through the distal end of thetube9′ to the outside.

After a series of members from thetube9 at one end to thetube9′ at the other end are filled with the priming fluid, thetubes9,9′ are squeezed by, e.g., clamps (not shown) to close their respective flow channels. Then, each of themale connectors1,1′ is disconnected from theadapter200 in the same manner asEmbodiment 1. Once theadapter200 is removed, thecovers4,4′ immediately expand and return to the initial state (seeFIG. 8B) due to their elastic recovery forces, thereby closing the openings of the lateral holes12,12′ of themale luers10,10′. Therefore, the priming fluid will not leak from themale luers10,10′ to the outside.

Consequently, the priming operation is finished.

Thereafter, similarly toEmbodiment 1, themale connectors1,1′ are connected to different female connectors800 (seeFIGS. 11A and 11B) to form extracorporeal circuits, respectively. Another priming operation for thefemale connectors800 and the tubes connected thereto has been completed.

Similarly toEmbodiment 1,Embodiment 2 also uses theadapter200 and can easily and hygienically introduce the priming fluid into themale luers10,10′ of the lever lockmale connector1,1′ having thecovers4,4′. Even if themale connectors1,1′ to which theadapter200 is connected at the first position are allowed to stand for a long period of time, the elastic recovery forces of the outercircumferential walls45,45′ of thecovers4,4′ will not be reduced. This can ensure the function of thecovers4,4′.

Further, themale connector1 and themale connector1′ are in communication with each other via theadapter200. Thus, the priming fluid can be simultaneously introduced into, e.g., themale connector1 for the blood removal line and themale connector1′ for the reinfusion line. Accordingly, the priming operation can be efficiently performed. The second priming method inEmbodiment 1 requires twoadapters100,100′ and thedrain connector150, and further requires an operation for connecting theadapters100,100′ and thedrain connector150. In contrast,Embodiment 2 uses only a single component, i.e., theadapter200 to simultaneously introduce the priming fluid into twomale connectors1,1′ by a simple operation procedure.

InEmbodiment 2, themale connectors1,1′ are connected to both ends of theadapter200. However, the present invention is not limited thereto, and the priming operation may be performed on themale connector1 in the same manner as the first priming method inEmbodiment 1 by connecting themale connector1 to thefirst end portion201 of theadapter200 while themale connector1′ is not connected to thesecond end portion202.

In theadapter200 inEmbodiment 2, thebase end113 of thetubular portion110 of thefirst end portion201 coincides with thebase end113′ of thetubular portion110′ of thesecond end portion202, and thefirst end portion201 and thesecond end portion202 share the singlelarge diameter portion105. However, the present invention is not limited thereto, and the basedend113 of thetubular portion110 may be spaced apart from thebase end113′ of thetubular portion110′ in the direction of thecentral axis200a. In this case, thebase end113 and thebase end113′ are coupled with a hollow member in which the throughhole203 is provided. The large diameter portions (a first large diameter portion and a second large diameter portion)105 are provided at the respective positions of thebase end113 and thebase end113′. Thefirst end portion201 including the firstlarge diameter portion105 is configured symmetrically to thesecond end portion202 including the secondlarge diameter portion105.

It should be understood thatEmbodiments 1, 2 are given by way of example only. The present invention is not limited toEmbodiments 1, 2, and modifications can be made thereto as appropriate.

It is possible to freely change how the liquid-tight seal is formed between thecover4 and each of thetubular portions110 of theadapters100,200 when theadapters100,200 are in the second position.

For example, theannular rib119a(119′) that protrudes from the shoulder portion119 (119′) of theadapters100,200 may be omitted. In this case, the shoulder portion119 (119′) directly abuts against thehead portion41 of thecover4 when theadapters100,200 are in the second position, and thus a liquid-tight seal can be formed between them.

Thehead portion41 of thecover4 does not need to have theupper surface43 that is parallel to the horizontal direction. Even if the surface of thehead portion41 that faces upward is, e.g., a spherical surface or a circular conical surface, a liquid-tight seal can be formed between such a surface and thetubular portion110.

In the above embodiments, when theadapters100,200 are connected to themale connector1 at the first position and the second position, thehead portion41 of thecover4 is inserted into thesecond region117 and thethird region118 of thetubular portion110. However, thesecond region117 and thethird region118 may be omitted. In this case, a liquid-tight seal is formed between the leading end of thetubular portion110 and thehead portion41 of thecover4 when theadapters100,200 are in the second position.

Thelarge diameter portion150 of theadapters100,200 may be omitted.

Thetapered surface112aof thesecond projection112 of theadapters100,200 may be omitted. Even in the absence of the taperedsurface112a, when theclaws32 include theinclined surfaces32a, theadapters100,200 can be moved from the first portion to the second position only by pushing theadapters100,200 into themale connector1.

Thefemale thread126 formed on the inner circumferential surface of theouter cylinder125 of theadapter100 may be omitted. Moreover, theouter cylinder125 may be omitted. If thesecond end portion102 includes only themale luer121, the male taperedsurface122 of themale luer121 can be connected to the female taperedsurfaces154a,154bof thedrain connector150 in a liquid-tight manner.

The configuration of themale connector1 is not limited to the above embodiments. The adapter of the present invention can be applied to any lever lock male connector including a lever with a claw to be engaged with a female connector.

For example, thehood20 of the male connector may have a cylindrical shape whose internal and external diameters are constant with respect to the direction of thecentral axis2a, as described inPatent Document 1. The number oflevers30 having theclaws32 is not limited to two, and may be, e.g., one, as described inPatent Documents 2, 3.

Theflow channel11 of themale luer10 may be open upward at theleading end10aof themale luer10, as described inPatent Document 1.

The throughhole42 formed in thehead portion41 of thecover4 does not have to be open so that the leadingend10aof themale luer10 is exposed in the initial state. For example, the throughhole42 may be a slit (cut portion) which looks like a minus sign (“−”), as described inPatent Documents 4, 5. In this case, the slit of the throughhole42 is closed when themale luer10 does not penetrate the throughhole42 in the initial state.

The outercircumferential wall45 of thecover4 may have any shape that can be elastically and compressively deformed in the longitudinal direction of themale luer10. For example, the outercircumferential wall45 may be in the form of bellows, as described inPatent Document 4.

In the above embodiments, the male connector is used for the extracorporeal circuit of blood. However, the present invention is not limited thereto. The male connector to which the adapter of the present invention is connected may be a male connector that constitutes a device other than the extracorporeal circuit, e.g., an infusion set used to perform infusion.

INDUSTRIAL APPLICABILITY

While there is no particular limitation on the field of use of the present invention, the present invention can be used as desired in the field of medicine where a priming fluid needs to be introduced into a lever lock male connector having a cover. In particular, the present invention can be preferably used in the field of, e.g., extracorporeal blood circulation or infusion where some liquid (blood, infusion solution, etc.) needs to be injected into a blood vessel of a patient.

LIST OF REFERENCE NUMERALS

1 Male connector

2 Connector main body

10 Male luer (male member)

11 Flow channel of male luer

20 Hood

30 Lever (lock lever)

32 Claw

4 Cover

41 Head portion

45 Outer circumferential wall

100,200 Adapter

101,201 First end portion

102,202 Second end portion

103,203 Through hole of adapter

105 Large diameter portion

110,110′ Tubular portion

111,111′ First projection

112,112′ Second projection

112aTapered surface

113,113′ Base end of tubular portion

119aAnnular rib

121 Male luer of adapter

122 Outer circumferential surface (male tapered surface) of male luer

125 Outer cylinder

126 Female thread (screw structure)

Claims (12)

The invention claimed is:

1. An adapter that is attachable to and detachable from a male connector,

the male connector comprising a rod-shaped male member that has a flow channel, a lock lever that is located opposite to the male member, a claw that protrudes from the lock lever toward the male member, and a cover that houses the male member,

wherein the lock lever is elastically swingable so that the claw moves away from the male member,

the cover includes an outer circumferential wall that is elastically and compressively deformable in a longitudinal direction of the male member, and a head portion that is provided at one end of the outer circumferential wall, and

the cover is configured such that a leading end of the male member protrudes from the head portion when the outer circumferential wall is compressively deformed,

the adapter comprising a first end portion and a second end portion,

wherein the adapter has a through hole that penetrates the adapter and allows the first end portion to be in communication with the second end portion,

the first end portion includes a hollow tubular portion in which the through hole is provided,

a first projection and a second projection are provided on an outer circumferential surface of the tubular portion, and the second projection is located on a base end side of the tubular portion with respect to the first projection,

the adapter can be connected to the male connector at a first position where the claw of the male connector is engaged with the first projection and at a second position where the claw of the male connector is engaged with the second projection,

when the adapter is connected to the male connector at the first position, the flow channel of the male member is sealed with the cover, and

when the adapter is connected to the male connector at the second position, the adapter compressively deforms the outer circumferential wall of the cover so that the flow channel of the male member is in communication with the through hole of the adapter.

2. The adapter according toclaim 1, wherein when the adapter is connected to the male connector at the second position, a liquid-tight seal is formed between the tubular portion and the cover.

3. The adapter according toclaim 2, wherein the tubular portion includes an annular rib that surrounds the through hole, and

the liquid-tight seal is formed by abutting of a leading end of the annular rib against the head portion of the cover.

4. The adapter according toclaim 1, wherein when the adapter is connected to the male connector at the first position, the outer circumferential wall of the cover is not substantially compressively deformed.

5. The adapter according toclaim 1, further comprising a large diameter portion on a base end of the tubular portion,

wherein the large diameter portion protrudes in a radial direction compared to the first projection and the second projection.

6. The adapter according toclaim 5, wherein the male connector further comprises a tubular hood that surrounds the male member, and

when the adapter is connected to the male connector at the second position, the large diameter portion abuts against a leading end of the hood.

7. The adapter according toclaim 1, wherein the first projection and the second projection are annular projections that continuously extend in a circumferential direction.

8. The adapter according toclaim 1, wherein the second projection has a tapered surface on an end edge thereof facing the first projection, and an external diameter of the tapered surface gradually decreases toward the first projection.

9. The adapter according toclaim 1, wherein the second end portion includes a male luer in which the through hole is provided, and

an outer circumferential surface of the male luer is a tapered surface whose external diameter gradually decreases toward a leading end.

10. The adapter according toclaim 1, wherein the second end portion of the adapter is configured symmetrically to the first end portion.

11. A male connector provided with an adapter, comprising:

the male connector and the adapter according toclaim 1.

12. The male connector provided with the adapter according toclaim 11, wherein the male connector provided with the adapter are sterilized and packaged in a state in which the adapter is connected to the male connector at the first position.

Images